Smoking Cessation With Varenicline in Schizophrenia: Antipsychotic-Induced Neurological Symptoms as Correlates

• Status: Unknown status
• Trial end date: 2020-06-30
• Target enrollment: 0
• Participant gender: All

Summary

To test the feasibility of studying effects of smoking cessation with varenicline on antipsychotic drug-induced neurological side effects, we propose a 12 week pilot study of smoking cessation treatment with varenicline in 10 schizophrenia or schizoaffective disorder patients who are actively smoking and have pre-existing TD while receiving stable doses of antipsychotics. Subjects will be followed after a 2 week baseline period to assess changes in smoking status and neurological symptoms using standardized rating scales. The aim is to examine clinically significant effects on antipsychotic-induced neurological side effects that may warrant further investigation.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Corporal Michael J. Crescenz VA Medical Center
• Treatments: Antipsychotic Agents; Varenicline

Criteria

Inclusion Criteria:

• DSM 5 criteria for schizophrenia or schizoaffective disorder and stable disease

• Glazer-Morgenstern-Doucette criteria for TD

• Smoking at least 5 cigarettes on average daily for at least 30 days prior to screening

• An exhaled carbon monoxide concentration greater than 5 parts per million (ppm) at screening

• Agree to stop smoking by the target date (four weeks after baseline

• Concurrence for varenicline treatment from the patient's mental health provider if the patient is under mental health care; OR, if the patient is not under mental health care, the prescribing clinician should consult with a mental health provider to evaluate the patient for appropriateness to receive varenicline

Exclusion Criteria:

• Have untreated or unstable acute medical or psychiatric illnesses

• Have a history of seizures

• History of somnambulism

• Have chronic degenerative neurological illnesses (e.g., Parkinson's disease)

• Have a history of active substance abuse (including marijuana abuse) in the 3 months prior to screening or a positive toxicology screen

• Are receiving clozapine or cholinesterase inhibitors

• Had a change in dosing or medication type of antipsychotic or anti-muscarinic for one month prior to enrollment (two months for long-acting antipsychotics)

• Are unable to remain on a stable dose of antipsychotic or anti-muscarinic during the study period

• Have acute suicidal ideation, intent or behavior within 12 months or risk based assessed on the C-SSRS or depression/anxiety score ≥ 8 on the HADS.

• Female subjects of childbearing age will have a negative pregnancy serum test at screening and are required to use approved methods of birth control

• Use of an investigational drug within 30 days of screening

• Use of other smoking cessation aids (bupropion, nicotine replacement products)

• Use of other tobacco products

• History of allergic reactions to varenicline

• Lack capacity to provide informed consent